Informed Consent: Moral Necessity Or Illusion?

Quality in Health Care 2001;10(Suppl I):i29–i33 i29 Qual Health Care: first published as 10.1136/qhc.0100029.. on 1 September 2001. Downloaded from Informed consent: moral necessity or illusion?

LDoyal

Abstract There is a professional and legal consen- Key messages sus about the clinical duty to obtain + There is a professional, legal, and moral informed consent from patients before consensus about the clinical duty to treating them. This duty is a reflection of obtain informed consent. wider cultural values about the moral + Patients have cognitive and emotional importance of respect for individual au- limitations in understanding clinical tonomy. Recent research has raised prac- information. tical problems about obtaining informed + Such problems pose practical problems consent. Some patients have cognitive and for successfully obtaining informed con- emotional problems with understanding sent. clinical information and do not apparently + Better communication skills among clini- wish to participate in making decisions cians and more eVective educational about their treatment. This paper argues resources are required to solve these that such research does not undermine problems. their potential to provide informed con- + Social and economic inequalities are sent. Rather, suYcient resources are re- important variables in understanding the quired to create better communication practical diYculties in obtaining in- skills among clinicians and more eVective formed consent. educational materials for patients. Fi- nally, cognitive and emotional inequality among patients is maintained to be a questioning the pursuit of informed consent in reflection of wider social and economic clinical care. Instead, it will be argued that what inequalities. Researchers who take the does follow from practical problems in obtain- right to informed consent seriously should ing informed consent is the need for specialised also address these. clinical training and other resources that will (Quality in Health Care 2001;10(Suppl I):i29–i33) support both clinicians and their patients in Keywords: patient preference; risk; informed choice; becoming partners in care. decision making; patient-caregiver communication Importance of informed consent: The recent literature on informed and shared a professional and legal consensus http://qualitysafety.bmj.com/ decision making within clinical care has There can be no doubt that respect for the right revealed a pronounced tension between three of patients to make informed choices is now competing factors: widely accepted as one of the key duties of any + Paternalistic conservatism about disclosure good health professional. Whatever practical of information to patients has been eroded problems may exist in fulfilling this clinical by moral arguments now largely accepted by duty, the institutions that shape the practice of the medical profession. medicine all confirm that patients should + While many patients may wish to be given accept or reject treatment proposals on the information about available treatment op- basis of information about what they are for, tions, many also appear to be cognitively and what they practically involve, and what their emotionally ill equipped to understand and risks are. These institutions include profes- on October 4, 2021 by guest. Protected copyright. retain it. sional bodies and the judiciary, as well as the + Even when patients do understand infor- advisory bodies that also influence professional mation about potential treatment options, opinion. This paper will focus on regulations they do no necessarily wish to make such within the UK. choices themselves, preferring to leave final The most important medical regulatory decisions in the hands of their clinicians. body in the UK is the General Medical Coun- The second and third factors are ostensibly cil which makes the following statement about St Bartholomew’s and at odds with the first. Given the diYculties they the importance of the principle of informed The Royal London pose, should we not recognise the utopian consent: School of Medicine nature of the goal of properly informed consent “Successful relationships between doctors and and Dentistry, Queen and return to the more honest and realistic patients depend on trust. To establish that trust you Mary & Westfield paternalism of the past? College, University of must respect patients’ autonomy—their right to London, London E1, This paper argues the contrary. After docu- decide whether or not to undergo any medical inter- UK menting the professional consensus surround- vention . . .”(They) . . . must be given suYcient L Doyal, professor of ing the goal of informed consent in clinical information, in a way that they can understand, in medical ethics practice, the practical obstacles to its achieve- order to enable them to make informed decisions ment will be explored. It will then be shown about their care.” 1 Correspondence to: Professor L Doyal that these constraints are not convincing as The GMC has the power to de-register any [email protected] either moral or empirical justifications for clinician found to be in breach of this principle.

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Legally, if patients believe that clinicians what they believe to be their best interests.16 17 have abused their right to make informed Even when patients do understand information choices about their care, they can pursue a about the nature, purpose, risks, and alterna- remedy in the civil courts for having been tives of proposed treatments, it is often quickly deliberately touched without their consent forgotten—so much so that it is unclear how it (battery) or for having received insuYcient could have ever constituted the foundation for information about risks (negligence). To avoid coherent deliberation about treatment the accusation of battery, clinicians need to choices.16 18 make clear what they are proposing to do and The reasons for the cognitive and emotional why “in broad terms”. With respect to limitations that lie behind such lack of compre- negligence, the amount of information about hension and memory are complex. They relate risks required is that deemed by the court to be both to specific characteristics of individual “reasonable” in light of the choices that patients themselves (maturity, education) and patients confront.23 also to the ways in which these have been influ- Legal standards of disclosure concerning enced by their socioeconomic background and informed consent diVer in diVerent jurisdic- environment.19 Yet clinicians have to deal with tions.4 For example, the legal standard in the individuals as they find them. Given the barri- UK is comparatively weak compared, for erstoeVective communication created by the example, with many parts of North America. varying potential of many patients to under- Indeed, it is sometimes argued that there is no stand and remember what they are told, would legal right to informed consent in the UK at all! not medical care be dramatically improved if Despite such claims, the law does give patients clinicians stopped pretending that they could the right to basic information about their pro- facilitate patient choice that is really educated? posed care and this has been reinforced by the Surely, it should be accepted that real informed 1998 Human Rights Act.5 Moreover, the law is consent is an illusion and that clinicians should constantly evolving and there is little doubt get on with the job of using their expertise to about the increasing seriousness with which the determine and to act upon what is in the best judiciary in the UK is underlining the right of interest of patients.20 patients to adequate information about their This proposal gains credibility from further proposed care.6 research which suggests that, even when This same respect for the right of patients to patients do understand treatment options and informed consent is evidenced in a variety of associated risks, they do not want the partner- advisory documents from other bodies con- ship in care embraced by regulatory and advi- cerned about the conduct of good clinical sory bodies. Rather, a significant proportion of practice.7–9 On the face of it, therefore, there is patients indicate that they wish their clinicians a professional and legal consensus in the UK to make final decisions about the treatment about the clinical duty to obtained informed they will receive and the risks they will take in consent for treatment and research, one which the process.21 To the degree that this is true, it is repeated in other parts of the world.10–12 adds further weight to the view that, in the overall process of providing good medical care, http://qualitysafety.bmj.com/ Informed consent: a professional and the moral importance of the communication of legal illusion? information can be overemphasised. On the The consensus about the importance of face of it the primary reason for this communi- informed consent for acceptable clinical prac- cation is to enable patients to choose for them- tice does not sit well with a wealth of recent selves. If they want little part in such choice, research findings about the problems of then what is the fuss all about? communicating relevant information to patients. Indeed, the problems revealed in these Why is informed consent so morally studies suggest that professional and legal important? demands to obtain informed consent could One thing is clear. An enormous amount mor- become vacuous and dangerous moral abstrac- ally hinges on how seriously we take these on October 4, 2021 by guest. Protected copyright. tions. The vacuity relates to the prescription of empirical findings that question the feasibility goals for good communication that seem and relevance of the clinical duty to obtain impossible to deliver in clinical practice. The informed consent. On the one hand, “ought danger lies in creating unrealistic expectations implies can”. Morally speaking, it is absurd to in patients about clinical communication, thus impute a duty that cannot be practically imperiling the very clinical relationship that fulfilled. On the other hand, great caution must informed consent and partnership in care are be exercised in any conclusion from the supposed to foster. research in question that the duty to obtain The most potentially damaging research informed consent should be foresworn or suggests that patients are unable to understand watered down. To do this would be to give up or remember the details of the information one of the most cherished moral prizes won required for educated choice. Some studies over the past two centuries—namely, the right appear to show that patients do not fully com- of individuals to exercise control over aspects of prehend basic information about conditions, their lives that they deem critical for whatever prognoses, and treatments.13–15 There are even reason.22 23 Thus, if we are to question the right more profound diYculties concerning the to informed consent on the grounds of practi- understanding of risks, a crucial category of cality, we had better be sure of our ground. On information that patients require in order to further inspection the grounds for scepticism make appropriate future plans and to act in are not as strong as they might at first appear.

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Although the research findings in question patients can indeed be fraught with diYculty. A are somewhat indeterminate, suppose for the high percentage of patients (and many clini- sake of argument that they do show that there cians) make fundamental errors in risk evalua- is little relationship between attempts to obtain tion, even when presented with the simplest informed consent and eVective clinical out- information.16 17 comes.24 If so, why should so much importance However, the fact that not all patients make be attached to attempting to provide patients such mistakes illustrates the possibility of with information that most of them will achieving better results with those who do. probably not understand? The diYculty with Research suggests, for example, that the such an argument can be illustrated by imagin- understanding of risk does improve when ing a colony of slaves who are of such great information is tailored to the personal charac- instrumental value to their owners that they are teristics and preferences of individual pa- provided with the best clinical care available.25 tients.28 Evidence also indicates that even better However, the slaves are told nothing about the results can be achieved by combining a variety care they will receive and are certainly not of methods of framing and communicating asked to consent to it. Such communication risks rather than presuming that any one and consent would entail extra work for the approach will suYce.28 29 In short, patients can hard pressed doctors in the slave colony and improve their understanding of risks and other would detract from the achievement of optimal aspects of clinical information. Given the moral clinical outcomes. Would there be anything unacceptability of doing otherwise, clinicians morally objectionable about such an approach? should do their best to encourage this potential Of course there would. Slavery is morally through taking the duty to try to obtain wrong precisely because it entails the denial of informed consent seriously. the right to refuse to allow one’s body to be Further research demonstrates that many used in specific ways. The immorality of the patients do desire information on their options scenario envisaged has nothing to do with the and that, given the opportunity, they will make scientific/technical quality of the medicine coherent clinical choices based on their knowl- practised or its outcomes and everything to do edge.30 For example, it has been shown that, with the moral circumstances in which it is over time, the individual patient will reason delivered. From one perspective, medical care quite similarly when presented with similar may well be beneficial and its practical benefit clinical decisions.31 The potential coherence of may have little to do with whether or not their decisions is important in light of the ten- patients choose it. Yet once the potential for dency of patients to forget clinical information such choice is removed, the care still remains about themselves.16 18 Thus, failure to remem- harmful. The harm in question is not physical ber does not constitute a good reason to ques- but moral. tion the right to informed consent. We all show Whatever the perceptions and preferences of forgetfulness in our everyday lives. The fact the slaves themselves—let us assume that they that we may also not remember the exact infor- have been brainwashed into passive acceptance mation upon which we made specific choices in of whatever care is provided—the fact remains life no way detracts from the moral importance http://qualitysafety.bmj.com/ that, in not providing them with information of our having been allowed to make them. about their proposed care and not obtaining Despite these arguments, it might still be their consent to it, one of the defining charac- argued that serious eVorts to educate patients teristics of their humanity will have been are not cost eVective. Even if many of the ignored. This is because humans have the abil- obstacles to good communication and under- ity to conceptualise the future and to make standing could potentially be overcome, to do choices about it in ways that animals do not.26 so may demand an unreasonable slice of scarce To the degree that medical care ignores rather healthcare resources. Such arguments would than nourishes this ability, then it harms be weak on their own terms, as well as having through failing to acknowledge the potential unacceptable moral implications. Evidence has that patients have as humans for exercising shown that the outcomes of clinical treatments on October 4, 2021 by guest. Protected copyright. control over their lives. Thus, if patients are can improve when patients have greater under- denied the information that they require to standing of their purposes and risks. To the consent validly to treatment, they are eVec- degree that this is so—and there is still much tively turned into slaves for medical purposes. research to be done here—there will be a direct The harm that endures may or may not be link between better communication with pa- accompanied by psychological suVering. Its tients and improvements in both the eYcacy reality takes the form of the objective indignity and the cost eVectiveness of care.32 to which the patients are subjected.27 Many patients have the potential for achieving greater clinical understanding and the The potential for informed choice positive desire to do so. They also have clear The prospect for such harm would not exist if preferences which may sometimes threaten there were there no potential for informed their well being and may be in conflict with choice. However, nothing in the research on their clinical advisors.33 This fact underlines the diYculties some patients have in under- the moral importance of honouring the prefer- standing clinical information suggests the ences of patients for informed participation in absence of such potential. All that the evidence the decision making process, while accepting shows is that, in educating patients, clinicians that this will not necessarily mean that they will sometimes face serious diYculties. For exam- always want to take final responsibility for the ple, the communication of clinical risks to details of all clinical decisions.34 For example,

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patients might reasonably assume that clini- Conclusions cians will not proceed with treatments that they This paper has argued that it does not follow decide are dangerous for some reason un- from research showing that patients have prob- known at the time that consent was given. In lems understanding and remembering infor- short, patients are not stupid. Why then do they mation that clinicians should not do their best so often exhibit such poor comprehension of to obtain informed consent for treatment. On related issues with such damaging conse- the one hand, much of this research reveals a quences for them and for the perception that self-fulfilling prophecy with patients. If clini- clinicians have of them? cians treat patients like children who should basically do as they are told, the consequence may well be patients who are unable to mobilise the skills to deal with clinical information and who lack the confidence to partici- Poor clinical communication: what pate in and to take responsibility for clinical should be done? choices about themselves.40 On the other hand, There is good evidence that many clinicians are 35 the evidence that has been reviewed demon- themselves poor communicators. Patients strates the ways in which this pattern of pater- have consistently protested about the failure to nalism can be broken. EVective training in communicate eVectively and this is believed to communication skills can make a genuine be one of the key causes of increasing patient diVerence to the success that clinicians have in litigation and even more time consuming educating their patients. formal complaints. Poor communication about What has not been argued, however, is that risks can lead to patients making potentially good communication skills and improved edu- dangerous decisions about their medical treat- cational material will completely resolve the ment.36 Equally, clinicians have themselves cognitive and emotional problems that patients revealed how inadequate their communication face. As is evidenced by the variability of rates is with patients, even in circumstances where it of understanding in relation to socioeconomic should be of a high standard—for example, background, much more profound social and obtaining informed consent for participation in political change will be required for significant research.37 Indeed, the evidence of poor reductions in such diVerences. This is hardly communication in medicine is so widespread surprising. Since the poor and uneducated are that it is unclear what sense to make of the disadvantaged in so many other walks of life, it research that suggests that patients are them- would be extraordinary if health care were an selves poor recipients of information. What is exception. This is why the struggle for more clear is that, if the potential of patients for bet- social equality is a prerequisite for improving the moral quality of all aspects of health care ter understanding is to be realised, clinicians provision, including the provision of infor- need to receive better training in communica- mation to patients and their ability to articulate tion skills. their preferences and to participate in decision Ample evidence now exists to confirm the making about their care. http://qualitysafety.bmj.com/ eVectiveness of teaching communication skills 37 to medical students and doctors. Through The author acknowledges the help of Lesley Doyal. such teaching, clinicians have improved their ability both to collect the information required 1 General Medical Council. Seeking patients’ consent: the ethical from patients for eVective diagnosis and considerations. London: General Medical Council, 1999: 2. 2 Chatterton v Gerson [1981] QB 432. treatment and also to educate them about their 3 Chantler C, Doyal L. Medical ethics: the duties of care in principle and practice. In: Powers M, Harris N, eds. Clini- treatment choices. Most clinicians have not cal negligence. London: Butterworths, 2000: 555–6. been properly trained in this regard, at least in 4deCruzP.Comparative health care law. London: Cavendish, 2001: 323–56. the UK. It is vital that they become so. 5 British Medical Association. The impact of the Human Rights Finally, even the best trained clinician will Act 1998 on medical decision making. London: British Medi-

cal Association, 2000. on October 4, 2021 by guest. Protected copyright. require more than good communication skills 6 Kennedy I, Grubb A. Medical law. London: Butterworths, to improve the standard of patient comprehen- 2000: 704–13. 7 Royal College of Surgeons. The surgeon’s duty of care. sion of clinical information and thus the proc- London: Royal College of Surgeons, 1997. 8 British Medical Association. Report of the consent working ess of informed consent itself. Good communi- party: incorporating consent tool kit. London: British Medical cation requires time and resources. When Association, 2001. 9 Department of Health. Reference guide to consent for examina- average consultation times are so short and tion or treatment. London: Department of Health, 2001. there is a paucity of well designed and 10 Canadian Medical Association. Code of ethics. Ottawa: Canadian Medical Association, 1996. produced literature and other informational 11 American Medical Association. Code of medical ethics. aids for patients, even the best communicators Chicago: American Medical Association, 1997. 12 Nicholson R. Informed consent and the regulation of medi- will be hard pressed to educate patients to their cal research: the European perspective. In: Doyal L, Tobias 38 39 J, eds. Informed consent and medical research. London: BMJ full potential. Time and educational mate- Books, 2000: 155–65. rials cost money in circumstances where the 13 Rogers AE, Addington-Hall JM, Abery AJ, et al. Knowledge and communication diYculties for patients with chronic resources of health services are or may be heart failure: qualitative study. BMJ 2000;321:605–7. increasingly stretched. In determining the level 14 Macillop W, Stewart W, Ginsburg A, et al. Cancer patients’ perceptions of their disease and its treatment. Br J Cancer of planning the funding of health care that is 1988;58:355–8. morally ﬁt for autonomous citizens, it is crucial 15 Sutherlund H, Lockwood G, Till J. Are we getting informed consent from patients with cancer? JRSocMed that the requirements of informed consent are 1990;83:439–43. allocated the moral importance that they 16 Lloyd A. The extent of patients’ understanding of the risk of treatments. Quality in Health Care 2001;10(Suppl I):i14– deserve. 18.

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17 Grimes DA, Snively GR. Patients’ understanding of medical 30 Richards T. Partnership with patients. BMJ 1998;316:85–6. risks: implications for genetic counselling and research. 31 Stanford JL, Feng Z, Hamilton AS, et al. Urinary and sexual Obstet Gynecol 1999;93:910–4. dysfunction after radical prostatectomy for clinically local- 18 Lloyd AJ, Hayes PD, London NJM, et al. Patients’ ability to ized prostate cancer. The prostate cancer outcomes study. recall risk associated with treatment options. Lancet 1999; JAMA 2000;283:354–60. 353:645. 19 Bowling A, Ebrahim S. Measuring patients’ preferences for 32 Coulter A. Partnerships with patients: the pros and cons of shared clinical decision-making. treatment and perceptions of risk. Quality in Health Care J Health Serv Res Policy 2001;10(Suppl I):i2–8. 1997;2:112–21. 20 Modi N. Ethical and legal issues in neonatal research. Semin 33 Montgomery A, Fahey T. How do patients’ treatment pref- Neonatol 1998;3:303–14. erences compare with those of clinicians? Quality in Health 21 Deber R. Physicians in health care management: 8. The Care 2001;10(Suppl I):i39–43. patient-physician partnership: decision making, problem 34 Guadagnoli E, Ward P. Patient participation in decision- solving and the desire to participate. Can Med Assoc J making. Soc Sci Med 1998;47:329–39. 1994;154:423–7. 35 Braddock CH, Edwards KA, Hasenburg NM, et al. 22 Doyal L, Gough I. A theory of human need. London: Informed decision making in an outpatient practice. JAMA Macmillan, 1991. 1999;282:2313–20. 23 McConnell T. Inalienable rights: the limits to informed consent 36 Dudley N. Importance of risk communication and decision in medicine and the law. New York: Oxford University Press, 2000: 1–78. making in cardiovascular conditions in older patients: a 24 Coulter A, Entwistle V, Gilbert D. Sharing decisions with discussion paper. Quality in Health Care 2001;10(Suppl patients: is the information good enough? BMJ 1999;318: I):i19–22. 318–22. 37 Hall A. The role of eVective communication in obtaining 25 Doyal L. Need for moral audit in evaluating quality in health informed consent. In: Doyal L, Tobias J, eds. Informed con- care. Quality in Health Care 1992;1:178–83. sent in medical research. London: BMJ Books, 2000: 291–8. 26 Leahy MPT. Against liberation: putting animals in perspective. 38 Elwyn G, Edwards A, Gwyn R, et al. Towards a feasible London: Routledge, 1991. model for shared decision-making: perceptions and reac- 27 Doyal L. Journals should not publish research to which tions of registrars in general practice. BMJ 1999;319:753– patients have not given fully informed consent—with three 6. exceptions. BMJ 1997;314:1107–11. 28 Edwards A, Glyn E. How well do patients understand the 39 Shepperd S, Charnock D, Gann B. Helping patients access concept of risk? Lessons for clinical risk communication. high quality health information. BMJ 1999;319:764–6. Quality in Health Care 2001;10(Suppl I):i9–13. 40 Robinson A, Thomson R. Variability in patient preferences 29 Edwards A, Pill RM, Stott NCH. Communicating risk: use for participating in medical decision making: implication of standard terms is unlikely to result in standard commu- for the use of decision support tools. Quality in Health Care nication. BMJ 1996;313:1483. 2001;10(Suppl I):i34–8. http://qualitysafety.bmj.com/ on October 4, 2021 by guest. Protected copyright.